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Observational Study on Impella 5.5 LVAD for End-Stage Heart Failure

This observational study is looking at how the Impella 5.5 left ventricular assist device (LVAD) helps patients with end-stage heart failure recover. Researchers want to see if using the Impella 5.5 LVAD can help the heart muscle improve (called reverse remodeling) and improve organ function. They will measure changes in your heart's pumping ability (Left Ventricular Ejection Fraction or LVEF), heart size (Left Ventricular End-Diastolic Diameter or LVEDD), and how much blood your heart pumps per minute (Cardiac Index) at the beginning and around day 40. You might be able to join if you are 18 or older, have dilated cardiomyopathy (a weakened and enlarged heart muscle) with an LVEDD over 5.5 cm and LVEF below 25%, and need the Impella 5.5 LVAD as a temporary support before a heart transplant. This study is currently enrolling about 50 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving a specific treatment. It plans to enroll about 50 participants.
What's involved
Participation is expected to last about 14 months, including a 1-3 day screening, 40-day treatment, and 1-year follow-up. Data will be collected for up to one year after a heart transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after the treatment period, and data will be collected for up to one year after a heart transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06800716

Impella Reverse Remodeling in End-Stage Heart Failure

Recruiting
Not specifiedAges 18+Observational
Columbia University
~50 participants
Updated 2026-08-19 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Left Ventricular Ejection Fraction (LVEF)
Measured over Baseline and approximately Day 40
+3 more outcomes measured

Conditions

Heart Failure
Cardiomyopathy

Explore related trials

Dilated CardiomyopathyHypertrophic CardiomyopathyRestrictive Cardiomyopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Adil Yunis, MS · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Adil Yunis, MD
[email protected]
212-305-0211
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 years or older
Dilated cardiomyopathy (LVEDD \> 5.5 cm and LVEF \<25%)
Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion

Exclusion

Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
Congenital heart disease
Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
Evidence of acute myocarditis by endomyocardial biopsy
Prior heart transplantation
Mechanical aortic / mitral valve
Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
Left Ventricular thrombus
Left Ventricular rupture
Cardiac tamponade
Presence of an Atrial or Ventricular Septal Defect
Severe right ventricular (RV) Failure requiring mechanical RV support
Severe peripheral vascular disease precluding placement of the Impella System
Recent stroke resulting in significant neurological deficit
Hypercoagulable disease precluding device implantation
Severe thrombocytopenia (\<50,000)
Contraindication to anticoagulation
Suspected or known pregnancy or lactating women
Subject belongs to a vulnerable population

What this trial measures

  • Change in Left Ventricular Ejection Fraction (LVEF)Baseline and approximately Day 40

    A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.

  • Change in Left Ventricular End-Diastolic Diameter (LVEDD)Baseline and approximately Day 40

    A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.

  • Change in Cardiac IndexBaseline and approximately Day 40

    A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).

  • Change in Pulmonary Capillary Wedge PressureBaseline and approximately Day 40

    A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).